NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 40 pharmaceutical companies such as RISING, IMPAX LABS INC, ACTAVIS ELIZABETH and others. It is marketed under 7 brand names, including DOXYCYCLINE HYCLATE, DOXYCYCLINE, DORYX and others. Available in 11 different strengths, such as EQ 100MG BASE, EQ 75MG BASE, EQ 150MG BASE and others, and administered through 4 routes including TABLET, DELAYED RELEASE;ORAL, INJECTABLE;INJECTION, TABLET;ORAL and others.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"84189","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX","family_id":"00eb0f2e4e2048d6b213","publication_number":"US8715724B2","cleaned_patent_number":"8715724","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-03","publication_date":"2014-05-06","legal_status":"Granted"} | US8715724B2 Formulation | 06 May, 2014 | Granted | 03 Feb, 2028 | |
| {"application_id":"84181","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"","publication_number":"US9295652B2","cleaned_patent_number":"9295652","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-23","publication_date":"2016-03-29","legal_status":"Granted"} | US9295652B2 Formulation | 29 Mar, 2016 | Granted | 23 Oct, 2034 | |
| {"application_id":"84184","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"320fe81ac46647bba61e","publication_number":"US9511031B2","cleaned_patent_number":"9511031","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-23","publication_date":"2016-12-06","legal_status":"Granted"} | US9511031B2 Formulation | 06 Dec, 2016 | Granted | 23 Oct, 2034 | |
| {"application_id":"84183","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"320fe81ac46647bba61e","publication_number":"US9446057B2","cleaned_patent_number":"9446057","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-23","publication_date":"2016-09-20","legal_status":"Granted"} | US9446057B2 Formulation | 20 Sep, 2016 | Granted | 23 Dec, 2034 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.